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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06354309
Other study ID # vr_study
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 1, 2023
Est. completion date October 20, 2023

Study information

Verified date April 2024
Source He Eye Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The research project titled "The Impact of Immersive Virtual Reality Training on Adult: Motion Sickness, and Ocular Surface: A Pilot Study" aimed to evaluate the initial safety impact of head-mounted virtual reality (HMVR) devices with virtual reality amblyopia training games on postural stability, motion sickness, and ocular surface in healthy adult participants. 38 adults (76 eyes) with normal corrected vision and stereo vision were recruited. All subjects used HMVR device for two consecutive training sessions (30 minutes each, 10 minutes intervals). Before training, after the first training and the second training, recorded the results including best corrected visual acuity (BCVA), ocular position, stereo vision, postural stability, non-invasive tear breakup time (NITBUT), tear meniscus height (TMH), red eye analysis, lipid layer classification (TFLL), eye blink frequency, eye surface temperature, simulator sickness questionnaire (SSQ) score, ocular surface disease index (OSDI) dry eye questionnaire score, visual quality questionnaire score and visual fatigue questionnaire score.


Description:

1. Title: The Impact of Immersive Virtual Reality Training on Adult: Motion Sickness, and Ocular Surface: A Pilot Study. 2. Purpose: To evaluate the initial safety impact of head-mounted virtual reality (HMVR) devices with virtual reality amblyopia training games on postural stability, motion sickness, and ocular surface in healthy adult participants. 3. Methods: A total of 38 healthy adult volunteers (18 males, 20 females) aged 18-42 years old were recruited from Shenyang He Eye Specialist Hospital from July to August 2023. Inclusion criteria: age ≥18 years; BCVA >=1.0; Titmus is between 40-60 ". Exclusion criteria: history of eye surgery and trauma within 3 months; Active eye problems; Pregnancy or lactation; Those who were determined by the investigator to be unsuitable for this study. This study was approved by the Ethics Committee of Shenyang He Eye Specialist Hospital (IRB(2023)K023.01). 3.1Research equipment Pico VR all-in-one (Neo2 Lite, Hainan Creative Vision Future Technology Co., LTD., China (referred to as "PICO") is a VR headset, which is used together with BeiShiYou visual function training software (BV-2, Shenyang BeiYou Technology Co., LTD., referred to as "BeiShiYou") 3.2 Procedure The procedure was divided into four steps: A. Sign the informed consent. B. First ophthalmic examination (diopter, BCVA, ocular position, stereo vision, postural stability, non-invasive tear breakup time, tear meniscus height, red eye analysis, lipid layer classification, eye blink frequency, eye surface temperature) and questionnaires survey (simulator sickness questionnaire, semans balance disorder scale, ocular surface disease index dry eye questionnaire, visual quality questionnaire and visual fatigue questionnaire). C. Conduct the first VR headset game training for 30 minutes, and then conduct the second eye examination and questionnaire survey above. D. Conduct the second VR headset game training for 30 minutes, and then conduct the third eye examination and questionnaire survey above (Figure 2). 3.3 Observation Indicators includes Simulator sickness questionnaire (SSQ), Postural stability, Non-invasive tear breakup time (NITBUT), Tear meniscus height, Lipid layer classification, Eye blink frequency, Central ocular surface temperature, Dry eye questionnaire score, Visual quality questionnaire score, Visual fatigue score.


Recruitment information / eligibility

Status Completed
Enrollment 38
Est. completion date October 20, 2023
Est. primary completion date October 20, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria: - Age >= 18 - Best vision >=1.0 - Titmus is between 40s and 60s Exclusion Criteria: - History of eye surgery and trauma within 3 months - Active eye diseases - Pregnancy and lactation period - Allergic to fluorescein sodium - The researcher determined that the subjects were not suitable for this study

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Virtual reality game
Pre and post control study after use virtual reality game

Locations

Country Name City State
China He Eye Hospital Shenyang Liaoning

Sponsors (1)

Lead Sponsor Collaborator
He Eye Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Simulator Sickness Questionnaire Score Record the simulator sickness questionnaire score after use virtual reality game Baseline, 30min, 60min
Secondary Postural stability Record the postural stability level after use virtual reality game Baseline, 30min, 60min
Secondary Non-invasive tear breakup time Check with Eye Surface Analyzer (OCULUS, Germany) Baseline, 30min, 60min
Secondary Tear meniscus height Check with Eye Surface Analyzer (OCULUS, Germany) Baseline, 30min, 60min
Secondary Lipid layer classification Check with DR-1 dry eye measurement Baseline, 30min, 60min
Secondary Eye blink frequency Collect the blink frequency with DJI Pocket 2 Creator Combo (Shenzhen DJI Innovation Technology Co., LTD.) Baseline, 30min, 60min
Secondary Eye surface temperature Collect eye surface temperature with Flir ONE Pro mobile phone Infrared thermal camera for Apple IOS (Teledyne FLIR, USA) Baseline, 30min, 60min
Secondary Ocular surface disease index dry eye questionnaire score Record with OSDI questionaire Baseline, 30min, 60min
Secondary Visual quality questionnaire score Record with visual quality questionnaire Baseline, 30min, 60min
Secondary Visual fatigue questionnaire score Record with visual fatigue questionaire Baseline, 30min, 60min
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